Quality Engineer - Temp

About Genalyte

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

The Quality Engineer will be a part of the Quality Assurance team s role will be responsible for ensuring compliance with applicable regulatory requirements and standards, maintaining quality system processes, and supporting the development and manufacture of IVD products. This is a temporary position.

These may include but are not limited to:

• Quality Systems Management:
  • Maintain and improve Quality Management System (QMS) processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory standards
  • Conduct internal audits and support external audits, including regulatory inspections
• Product Development Support:
  • Support product design team in the development and release of product specifications and documentation
  • Collaborate with cross-functional teams to ensure design controls, risk management, and product validations comply with regulatory and quality requirements
  • Participate with design teams in the development of quality requirements, acceptance criteria and test methods for components, assemblies and devices
  • Participate in design reviews and ensure proper documentation of design history files (DHF)
  • Support phase gate reviews for development projects at scheduled intervals and ensure compliance to design control regulations
  • Prepare quality related deliverables per the design control process
• Manufacturing Support:
  • Work closely with product teams to develop and approve manufacturing process documents (procedures, work instructions)
  • Develop manufacturing process quality requirements and methods needed to support manufacturing
  • Prepare or support equipment qualification and process validation protocols release, execution and reports
• Supplier Quality Management:
  • Working with Supply Chain and QA, qualify suppliers in accordance with company processes and regulatory requirements
  • Evaluate and monitor supplier performance to ensure materials and components meet specifications
  • Perform acceptance activities for supplied materials, as needed
• Compliance and Documentation:
  • Ensure proper documentation and traceability of quality records, including complaints, deviations, and change controls
  • Perform quality trend analyses to demonstrate quality system effectiveness and compliance
• Other tasks as assigned

• A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related field with 3 years of experience in quality engineering within the medical device or IVD industry
• Strong knowledge of ISO 13485 and FDA QSR
• Proficiency in quality tools and methodologies, such as FMEA, SPC, and Root Cause Analysis
• Experience with CAPA, nonconformance investigations, and risk management
• Excellent problem-solving, analytical, and organizational skills
• Strong communication and collaboration abilities
• Preferred Qualifications:
  • Certified Quality Engineer (CQE) or equivalent certification
  • Experience with statistical analysis tools and software
  • Familiarity with software quality assurance for medical devices

The base range for this role is $39-$48 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training.